The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Mri Equipment Cover.
| Device ID | K993682 |
| 510k Number | K993682 |
| Device Name: | MRI EQUIPMENT COVER |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Contact | David M Lee |
| Correspondent | David M Lee IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 2000-01-20 |